Senior Director, Global Regulatory Strategy 

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.   Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.  You can view our latest corporate deck and other presentations https://ir.olema.com/. About the Role >>> Senior Director, Global Regulatory Strategy  As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:   Leading the development and execution of innovative regulatory strategies supporting Olema products   Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)   This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%.  Your work will primarily encompass:   Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed   Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee   Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)   Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)   Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives   Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management  Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements   Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams   Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)    Participate in and contribute to cross-functional and departmental objectives   Maintain flexibility to adapt and accommodate additional duties as assigned   And will also include the following:   Lead the development of Regulatory Affairs department policies, SOPs, and work instructions   Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)   Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs   Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives   Mentor and develop colleagues in the Regulatory department    Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader   A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.   Knowledge:   Bachelor’s degree in a scientific discipline   Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred    Experience:   12 years’ experience in Regulatory Affairs in Pharma/Biotech   Minimum of 3 years direct leadership experience   Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions   Experience with leading the NDA/BLA or Marketing Applications is desirable.)  Experience in Oncology Therapeutic area is required  Experience with development and execution of regulatory strategies in Oncology TA is required   Ability to work in a fast-paced environment in a hands-on fashion   Excellent oral, written, and presentation skills   Strong organizational skills   Attributes:   Self-starter   Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities The base pay range for this position is expected to be $270,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.  #LI-MK1 Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated. We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you. Fraud Alert:  We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is https://olema.com/; our careers page is https://olema.com/careers/; our LinkedIn page is https://www.linkedin.com/company/olema-oncology/. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview. Offices: San Francisco, California, United States (Brannan / SF); San Francisco, California, United States (Owens / SF); Boston, Massachusetts, United States (Rogers / Boston);